Create the coding target fields

Create the necessary coding target fields to store the details extracted from an Oracle Central Coding dictionary. For example, System Organ Class Term and Code for a MedDRA dictionary, and Trade Name Term and Code for a WHO DD dictionary.

Note:

Advanced Study Versioning (ASV) does not support the addition of new coding target fields for existing subjects.

You can certainly add new coding targets using ASV and it would result in the new fields displaying on the forms for all existing and new subjects in Oracle Clinical One Platform. However, for existing subjects for which the given visit was initiated (before the new coding targets were added), the new fields for coded verbatim terms are not populated in Oracle Central Coding.

This is because the code map, comprised of the mappings between form questions and the applicable dictionary level, is established and locked for a subject when the visit is initiated. For more information, see About Advanced Study Versioning (ASV)

  1. Open the form, click Add, and select the Text option.
  2. Enter the question title, for example, System Organ Class Code.
  3. On the Details side panel.
    • Disable the Required toggle. Coding targets should not be required.
    • Enable the Hidden toggle and use data classification to define who can view the data. For more information, see Define data classifications for a hidden question.
    • Enable the Read Only toggle so users can not edit the data.

      Note:

      Coding targets should never be editable. Study design and Oracle Central Coding configuration determine the data that populates these fields.
    • Set the Character Limit to 2000.
  4. Expand the Advanced side panel, click Add Property, and select Coding Question.
    The Dictionary and Tag for Central Coding settings are populated with the values defined for the verbatim term; do not change these.
  5. Select the matching value under Coding Item Type.
  6. Click Save, then Add to create additional coding targets.